• Karin S Coyne, Mary Kay Margolis, Linda D Bradley, Richard Guido, G Larry Maxwell, and James B Spies.
• United BioSource Corporation, Bethesda, MD 20814, USA. karin.coyne@unitedbiosource.com
• Value Health. 2012 Jan 1; 15 (1): 135-42.

ObjectiveTo further examine the reliability, validity and responsiveness of the uterine fibroid symptom and quality-of-life (UFS-QOL) questionnaire among women with and without uterine fibroids.MethodsA multicenter, non-randomized, prospective study was conducted with women undergoing treatment for uterine fibroids (fibroid treatment group [FTG]) and normal controls (normal control group [NCG]). Women in the FTG were recruited when they were scheduled for treatment; women in the NCG were recruited during their annual exam. Participants completed the UFS-QOL and a short form 36 health survey (SF-36) at enrollment and at 6 and 12 months. Descriptive statistics, Cronbach's alpha, Spearman's correlations, t tests, and general linear models were used to analyze the internal consistency and test-retest reliability, concurrent and discriminant validity, and responsiveness of the UFS-QOL.ResultsThere were 89 NCG and 234 FTG women who completed the study. Mean age was 43.1 years for FTG and 40.8 for NCG (P < 0.001). The FTG reported significantly greater symptom severity and worse health-related quality of life (HRQL) than the NCG (all UFS-QOL subscales P < 0.001). The UFS-QOL subscales were significantly correlated in the expected direction and magnitude with each SF-36 subscale in the FTG, indicating acceptable concurrent validity. Cronbach's alphas were 0.73 to 0.97, reflecting adequate internal consistency. Each UFS-QOL subscale was responsive to changes after treatment in the FTG with effect sizes ranging between 1.1 and -2.35. The UFS-QOL remained stable in the NCG during the 1 year follow-up.ConclusionThe UFS-QOL is a valid and reliable measure to assess symptoms and HRQL in women with uterine fibroids and is highly responsive to treatment-related changes.Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

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